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FDA 510(k)

Pivot Insulin Delivery System

K-Number: K253534 · 2026-04-08

ApplicantModular Medical
Decision Date2026-04-08
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pivot Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Modular Medical. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K253534. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pivot Insulin Delivery System?

Pivot Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Modular Medical. The 510(k) number is K253534.

When did Pivot Insulin Delivery System receive FDA 510(k) clearance?

Pivot Insulin Delivery System received FDA 510(k) clearance on 2026-04-08, under 510(k) number K253534.

Who is the listed applicant for Pivot Insulin Delivery System?

The FDA 510(k) record lists Modular Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pivot Insulin Delivery System?

The FDA product code for Pivot Insulin Delivery System is LZG.

Other records listing Modular Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240158Modular Medical MODD1 Insulin Delivery System

Related Devices (Code: LZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet CorporationK192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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